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YHEC authors: Julie Glanville
Publication date: May 2019
Publishers: The Handbook of Research Synthesis and Meta-Analysis

Abstract

Research synthesis is the practice of systematically distilling and integrating data from many studies in order to draw more reliable conclusions about a given research issue. When the first edition of The Handbook of Research Synthesis and Meta-Analysis was published in 1994, it quickly became the definitive reference for conducting meta-analyses in both the social and behavioral sciences. In the third edition, editors Harris Cooper, Larry Hedges, and Jeff Valentine present updated versions of classic chapters and add new sections that evaluate cutting-edge developments in the field.

The Handbook of Research Synthesis and Meta-Analysis draws upon groundbreaking advances that have transformed research synthesis from a narrative craft into an important scientific process in its own right. The editors and leading scholars guide the reader through every stage of the research synthesis process-problem formulation, literature search and evaluation, statistical integration, and report preparation. The Handbook incorporates state-of-the-art techniques from all quantitative synthesis traditions and distills a vast literature to explain the most effective solutions to the problems of quantitative data integration. Among the statistical issues addressed are the synthesis of non-independent data sets, fixed and random effects methods, the performance of sensitivity analyses and model assessments, the development of machine-based abstract screening, the increased use of meta-regression and the problems of missing data. The Handbook also addresses the non-statistical aspects of research synthesis, including searching the literature and developing schemes for gathering information from study reports. Those engaged in research synthesis will find useful advice on how tables, graphs, and narration can foster communication of the results of research syntheses.

The third edition of the Handbook provides comprehensive instruction in the skills necessary to conduct research syntheses and represents the premier text on research synthesis.

Peer-reviewed publication

A Systematic Review and Cost Analysis of Repeat Colonoscopies Due to Inadequate Bowel Cleansing in Five European Countries

YHEC authors: Michelle Jenks, Rachael McCool, Hannah Wood, Victoria Young
Publication date: April 2019
Journal: Expert Review of Pharmacoeconomics & Outcomes Research

Abstract

BACKGROUND: Colonoscopies are carried out for a range of reasons including for the detection of colon cancer and investigation of abdominal and bowel related symptoms. Inadequate preparation can increase the burden of repeat procedures.

METHODS: A systematic review aimed to identify the rate of repeat colonoscopies due to inadequate bowel preparation in France, Germany, Italy, Spain and the United Kingdom. The information obtained populated a decision analytic model to estimate the cost implications of inadequate bowel cleansing in the same five countries. The model explored scenarios by comparing one and two-litre polyethylene glycol-based bowel preparation.

RESULTS: The systematic review identified 14 eligible studies reporting on the proportion of patients with inadequate bowel cleansing indicated for a repeat procedure. Data were available for Italy (27.5%-35.9%), Spain (63%) and the UK (24.5%) only. The decision analytic model demonstrates that improving the proportion of adequate bowel cleansing at first colonoscopy is likely to generate cost savings.

CONCLUSIONS: Based on the available evidence, increasing the proportion of people who have adequate bowel cleansing at index colonoscopy will likely have financial benefits in Italy, Spain and the UK. A paucity of data, for France and Germany, limits the robustness of conclusions in these countries.

Peer-reviewed publication

Cost-Effectiveness of a Dialkylcarbamoyl Chloride-Impregnated (DACC) Surgical Dressing to Prevent Surgical Site Infection Dollowing Caesarean Section

YHEC authors: Heather Davies, Jessica McCaster, Stuart Mealing
Publication date: April 2019
Journal: Journal of Wound Care

Abstract

OBJECTIVE: A randomised controlled trial (RCT) recruited women undergoing caesarean section (CS) in Poland. The aim of the trial was to assess the efficacy of a dialkylcarbamoyl chloride (DACC)-impregnated surgical dressing (bacterial-binding dressings) compared with standard of care (SoC) in preventing surgical site infection (SSI). The aim of the present analysis was to evaluate the cost-effectiveness of the bacterial-binding dressings in the context of the UK National Health Service (NHS).

METHOD: The clinical trial randomised patients to a bacterial-binding dressing (n=272) or a standard surgical dressing (n=271). The study recorded the presence of SSI and associated resource use up to 14 days postoperatively. To generalise results to the NHS, UK unit costs were applied to resource use recorded in the trial. An alternative approach applied a single UK-specific episode cost per SSI.

RESULTS: There were 543 women recruited to the trial. SSI rates were 5/272 (1.8%) and 14/271 (5.2%) for bacterial-binding dressings and SoC, respectively (p=0.04). Patients in the bacterial-binding dressing group had six fewer outpatient visits and 33 fewer hospital bed-days. The mean length of SSI-attributable hospitalisation was 2.36 days. Applying UK unit costs at 2017 prices to resource use recorded in the trial, costs of SSI prophylaxis and treatment were £48.97 and £24.69 per patient in the SoC and bacterial-binding dressing groups respectively, a difference of £24.27 (49.6%) per patient. The alternative costing approach produced a cost saving of £119 (57.6%) per patient with the bacterial-binding dressing.

CONCLUSION: Use of bacterial-binding dressings following CS has the potential to reduce the incidence of SSI and costs to the NHS.

Report

Explanatory Note on Literature Searching Conducted in the Context of GMO Applications for (Renewed) Market Authorisation and Annual Post-Market Environmental Monitoring Reports on GMOs Authorised in the EU Market

YHEC authors: Julie Glanville
Publication date: April 2019
Publishers: EFSA supporting publications

Abstract

Guidance of the Panel on Genetically Modified Organisms (GMOs) of the European Food Safety Authority (EFSA) assists applicants in the preparation and presentation of their market registration applications by describing elements and information/data requirements for the risk assessment and monitoring of GMOs. This explanatory note to the guidance: (1) clarifies the scope and methodology for literature searching performed in the context of applications for market authorisation of GMOs submitted under Regulation (EC) No 1829/2003 before and after the Implementing Regulation (EU) No 503/2013 entered into force; annual post-market environmental monitoring reports on GMOs authorised in the EU market; and GMO applications for the renewed market authorisation of GM food/feed authorised under Regulation (EC) No 1829/2003; and (2) provides detailed recommendations on how to conduct and report systematic/extensive literature searches, and present the results of any scoping reviews.

Peer-reviewed publication

Mepilex Border Sacrum and Heel Dressings for the Prevention of Pressure Ulcers: A NICE Medical Technology Guidance

YHEC authors: Chris Marshall, Judith Shore, Mick Arber, Rachael McCool, Michelle Jenks
Publication date: March 2019
Journal: Applied Health Economics and Health Policy

Abstract

Mepilex Border Sacrum and Heel dressings are self-adherent, multilayer foam dressings designed for use on the heel and sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention. The National Institute for Health and Care Excellence (NICE) selected Mepilex Border Sacrum and Heel dressings for evaluation. The External Assessment Centre (EAC) critiqued the company's submission. Thirteen studies (four randomised controlled trials and nine nonrandomised comparative studies) were included. The majority of studies compared Mepilex Border Sacrum dressings (plus standard care) with standard care alone. Comparative evidence for Mepilex Border Heel dressings was limited. A meta-analysis indicated a non-statistically significant difference in favour of Mepilex Border Sacrum dressings for pressure ulcer incidence [RR 0.51 (95% CI 0.22-1.18)]. The company produced a de novo cost model, which was critiqued by the EAC. After the EAC updated input parameters, cost savings of £19 per patient compared with standard care alone for pressure ulcer prevention were estimated with Mepilex Border dressings predicted to be cost saving in 57% of iterations. The Medical Technologies Advisory Committee reviewed the evidence and judged that, although Mepilex Border Heel and Sacrum dressings have potential to prevent pressure ulcers in people who are considered to be at risk in acute care settings, further evidence is required to address uncertainties around the claimed benefits of the dressings and the incidence of pressure ulcers in an NHS acute-care setting. After a public consultation, NICE published this as Medical Technology Guidance 40.

Peer-reviewed publication

The Impact of Increased Post-Progression Survival on the Cost-Effectiveness of Interventions in Oncology

YHEC authors: Heather Davies, Matthew Taylor
Publication date: March 2019
Journal: ClinicoEconomics and Outcomes Research

Abstract

PURPOSE: Cost-effectiveness analyses (CEA) of new technologies typically include "background" costs (eg, all "related" health care costs other than the specific technology under evaluation) as well as drug costs. In oncology, these are often expensive. The marginal cost-effectiveness ratio (ie, the extra costs and QALYs associated with each extra period of survival) calculates the ratio of background costs to QALYs during post-progression. With high background costs, the incremental cost-effectiveness ratio (ICER) can become less favorable as survival increases and the ICER moves closer to the marginal cost-effectiveness ratio, making cost-effectiveness prohibitive. This study assessed different methods to determine whether high ICERs are caused by high drug costs, high "background costs" or a combination of both and how different approaches can alter the impact of background costs on the ICER where the marginal cost-effectiveness ratio is close to, or above, the cost-effectiveness threshold.

METHODS: The National Institute for Health and Care Excellence oncology technology appraisals published or updated between October 2012 and October 2017 were reviewed. A case study was selected, and the CEA was replicated. Three modeling approaches were tested on the case study model.

RESULTS: Applying one-off "transition" costs during post-progression reduced the ongoing "incremental" costs of survival, which meant that the marginal cost-effectiveness ratio was substantially reduced and problems associated with additional survival were less likely to impact the ICER. Similarly, the use of two methods of additional utility weighting for end-of-life cases meant that the marginal cost-effectiveness ratio was reduced proportionally, again lessening the impact of increased survival.

CONCLUSION: High ICERs can be caused by factors other than the cost of the drug being assessed. The economic models should be correct and valid, reflecting the true nature of marginal survival. Further research is needed to assess how alternative approaches to the measurement and application of background costs and benefits may provide an accurate assessment of the incremental benefits of life-extending oncology drugs. If marginal survival costs are incorrectly calculated (ie, by summing total post-progressed costs and dividing by the number of baseline months in that state), then the costs of marginal survival are likely to be overstated in economic models.

Peer-reviewed publication

A Cost-Effectiveness Analysis of Endoscopic Eradication Therapy (EET) for Management of Dysplasia Arising in Patients with Barrett’s Esophagus in the United Kingdom

YHEC authors: Vicki Pollit, Jessica McCaster, Stuart Mealing
Publication date: January 2019
Journal: Current Medical Research & Opinion

Abstract

BACKGROUND AND AIMS: Endoscopic eradication therapy (EET) is the first line approach for treating Barrett's oesophagus (BE) related neoplasia globally. The British Society of Gastroenterology (BSG) recommend EET with combined endoscopic resection (ER) for visible dysplasia followed by endoscopic ablation in patients with both low and high grade dysplasia (LGD and HGD). The aim of this study is to perform a cost-effectiveness analysis for EET for treatment of all grades of dysplasia in BE patients.

METHODS: A Markov cohort model with a lifetime time horizon was used to undertake a cost-effectiveness analysis. A hypothetical cohort of UK patients diagnosed with BE entered the model. Patients in the treatment arm with LGD and HGD received EET and patients with non-dysplastic BE (NDBE) received endoscopic surveillance only. In the comparator arm, patients with LGD, HGD and NDBE received endoscopic surveillance only. A UK National Health Service (NHS) perspective was adopted and the incremental cost-effectiveness ratio (ICER) was calculated. Sensitivity analysis was conducted on key input parameters.

RESULTS: EET for patients with LGD and HGD arising in BE is cost-effective compared to endoscopic surveillance alone (lifetime ICER £3006 per quality adjusted life year [QALY] gained). The results show that, as the time horizon increases, the treatment becomes more cost-effective. The 5 year financial impact to the UK NHS of introducing EET is £7.1m.

CONCLUSIONS: EET for patients with low and high grade BE dysplasia, following updated guidelines from the BSG, has been shown to be cost-effective for patients with BE in the UK.

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